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Tuesday, December 12, 2017
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Who will heal our drug industry?
There has been little done by either the influential pharmaceutical industry or the government to improve the quality of medicines sold in less-regulated markets like India
On March 11, the Supreme Court dismissed two Public Interest Litigations (PILs) that I had filed praying for an urgent reform of India’s drug regulatory framework. Both PILs were part of an effort that I personally funded and led for the last two and a half years. The motivation for both PILs came directly from my experience as a whistleblower in the Ranbaxy case. The data fabrication and duplicity that I discovered at Ranbaxy led me to resign from the company and report the violation of law to the U.S. Food and Drug Administration (USFDA). That case ended with penalties of $500 million on Ranbaxy and, more importantly, led to an increased scrutiny by the USFDA and other foreign regulators. This also resulted in a heightened focus on quality-related issues within the Indian pharmaceutical industry.
Unfortunately, the entire focus on improving quality has been targeted at only those manufacturing facilities that make products for export to lucrative Western markets. There has been little done by either the industry or the government to improve the quality of medicines sold in less-regulated markets like India — and its poorer neighbours in Asia and in Africa.
Negative health outcomes
As an Overseas Citizen of India (OCI), it alarmed me that substandard medicines were causing negative health outcomes, an increasing antibiotic resistance and a waste of public money. I initially tried approaching the government to highlight the issues. In 2014, I managed to secure a meeting with the then Health Minister. He appeared to be uninterested. I then spent the next two years meeting or trying to meet retired and serving bureaucrats in the Ministry of Health to impress upon them the urgent need for reform. The uniformly consistent answer I received comprised an advice to approach the Supreme Court through a PIL. I was told that the pharmaceutical industry is politically very powerful and has used its influence in the past to block reforms initiated by the government. As a result, I re-focussed my energies on working with a team of lawyers to lay the ground work for the PILs that were heard earlier this month.
This was a difficult, expensive and time-consuming process. There are no academic bodies or think tanks which have researched the issues with focus on India’s drug regulatory framework.
In the last few months, we embarked on a massive research exercise, which involved trawling through numerous government reports, filing over 125 Right to Information (RTI) applications and extracting information from different state regulators on the manner of enforcement of the Drugs and Cosmetics Act, 1940.
What we discovered was alarming because the issue was worse than I had ever imagined. Successive reports of the Comptroller and Auditor General (CAG) had found an alarmingly high rate of substandard medicines being prescribed in publicly-funded programmes like the Central Government Health Scheme (CGHS) and places like the Railway Hospitals and the Armed Forces Medical Stores Depots (AFMSD). The CAG’s audit report of the AFMSD, which serves our Armed Forces Personnel and their families, showed the percentage of locally procured substandard drugs at a high 32 per cent in one year.
A Parliamentary Standing Committee Report in 2012 had discovered that European companies were selling medicines in India that had not been approved in their home countries, or, for that matter, in any developed country. A subsequent report noted that the Ministry of Health had failed to investigate the officials who granted such ‘illegal’ approvals despite the Ministry giving a written commitment to Parliament.
The story of ignored recommendations repeated itself in the case of the Expert Committee headed by Dr. V.M. Katoch in 2012 and another Expert Committee headed by Dr. Ranjit Roy Chaudhury in 2013. The latter had recommended making mandatory basic quality testing such as bioequivalence studies for all generic drugs. The Drug Consultative Committee (DCC) rejected the recommendation on the grounds that India apparently lacked the infrastructure. In the same breath, it encouraged such testing for exports because countries like the U.S. will not accept any drug formulation which is not proven bioequivalent.
This consistent pattern of the government ignoring recommendations by its own experts is mirrored in the enforcement of India’s existing, already weak, drug regulations. We found that investigations conduced by drug inspectors in individual States were mostly a sham since they lacked the necessary resources to coordinate their activities across different States. Often, the manufacturer would be located in Himachal Pradesh or Uttarakhand and the substandard drug would be sold in States like Karnataka or Maharashtra. Only a minority of such cases resulted in a prosecution. Even in those cases, judges wilfully ignored the mandatory sentencing provisions of at least one year of imprisonment, preferring instead a “simple imprisonment till the rising of the court”. This allowed the convicted person to walk free as soon as the judge rose for the day. Monetary fines were in a lenient five-digit range for products worth lakhs or crores. After a comprehensive study, it was clear to us that the system was dysfunctional at every stage.
What made matters worse was that even States like Tamil Nadu, where the drug inspectors are of a high calibre, could do little to stop the flooding in of substandard drugs from Himachal Pradesh or Uttarakhand. This is because only the governments in the respective States can cancel the licences of the erring drug manufacturers located there. We discovered that expert committees — beginning in the year 1955 — have repeatedly recommended that licensing be made centralised. Further, two legislative efforts in 2007 and 2013 to centralise such regulations failed because of sabotage by the Indian pharmaceutical industry.
The PILs I filed offered the best chance to start with a clean slate. As we see from the arguments being proffered by the industry to challenge the ban on the Fixed Dose Combinations in the Delhi High Court, it is a daunting process to reform the system. And the matter before the court is only a small slice of the bigger problem. There is complicity in the creation of this dysfunctional system amongst all levels of the official machinery and the current regulatory framework is riddled with holes.
The effects of substandard medicines and poor drug regulations that lead to their sale are similar to the effects of climate change. They are difficult to quantify and sometimes hard to prove but this is certainly not a mere academic issue. Apart from a failure to cure diseases, the effects of such substandard drugs include growing antibiotic resistance and the birth of deathly superbugs. The long-term effects will be devastating to public health, especially to the poor and vulnerable.
Keeping in mind the catastrophe substandard medicines pose to the health of my family, my friends and my fellow citizens, I approached both the government and the Supreme Court of India for justice. Unfortunately, the Honourable Court declined to hear my plea. Where do I go now to seek reforms to this dysfunctional system?
Dinesh S. Thakur is the Executive Chairman of Medassure Global Compliance Corporation.... More
 
 
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